Observational Evaluation of the Peristomal Skin Condition in Ostomates

Status unconfirmed

Conditions studied: Ostomy

In brief

The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.

Key facts

Study ID

NCT01526967

Run by

ConvaTec Inc.

People needed

2000

Starts

2012-01-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are 18 years old and older.
• Subjects who agree to participate in the evaluation and who have signed the informed consent form.
• Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
• Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
• OR
• Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.

You may not qualify if…

• Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
• Subjects who are in a simultaneous clinical evaluation.

Where it is running

• RI Colorectal Clinic, LLC — Pawtucket, Rhode Island, United States
• San Jacinto Methodist Hospital — Baytown, Texas, United States
• NW Pavillion Ostomy Clinic — Renton, Washington, United States
• Independent Nurse Consultant — Tucson, Arizona, United States
• John Muir Health Concord Campus — Concord, California, United States
• Conn. Clinical Nursing Associate, LLC — Plymoth, Connecticut, United States
• Baptist Home Health — Jacksonville, Florida, United States
• Porter Hospital — Valparaiso, Indiana, United States
• Serena Group - Dr. Thomas Serena MD — Cambridge, Massachusetts, United States
• Henry Ford Macomb Hospital — Clinton Township, Michigan, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• St. Anthony's Medical Center — St Louis, Missouri, United States
• ID Med Inc. — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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